- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00243308
Serp-1 for the Treatment of Acute Coronary Syndrome
February 5, 2009 updated by: Viron Therapeutics Inc
A Phase 2, Multicentre, Double-Blind, Placebo-Controlled, Dose Escalating Trial of the Safety, Pharmacokinetics, and Biological Activity of 3 Consecutive Daily Doses of Serp-1 When Added to Conventional Therapy in Patients With Acute Coronary Syndromes (Non ST-Elevation Myocardial Infarction and/or Unstable Angina)
Males and females aged 18-80 years who present with ACS (unstable angina and non ST-elevation MI) defined as one or more episodes of angina lasting at least 5 minutes in the last 24 hours before admission and greater than 0.05 mV of presumed new ST-segment depression in at least 2 contiguous ECG leads OR, angina and per confirmatory angiogram, has been scheduled for percutaneous coronary angioplasty.
The primary objective of this study is to evaluate the safety of Serp-1 injection when administered in 3 daily doses to patients undergoing conventional therapy for Acute Coronary Syndrome (ACS) requiring early intervention.
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
A total of 72 subjects will be enrolled, separated into 3 dose groups and centrally randomized in a 3:1 ratio of Serp-1 injection to placebo control.Subjects will receive Serp-1 by intravenous (IV) bolus injection daily for 3 days, at dose levels of 5.0, 15, and 50 ug/kg/dose or placebo (0.9% normal saline) added to any prescribed therapy for ACS.
Serp-1 will be administered as a single IV bolus injection.
The initial IV bolus dose is administered immediately preceding the PCI procedure with subsequent doses administered 24 and 48 hours later.Subjects will be evaluated for adverse events, serum inflammatory markers and restenosis rates at 6 months post-dose.
Study Type
Interventional
Enrollment (Anticipated)
72
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vicotria, British Columbia, Canada, V8R 4R2
- Victoria Heart Institute
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Ontario
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Calgary, Ontario, Canada, T2N 2T9
- Foothills Medical Center
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London, Ontario, Canada, N6A 5C1
- London Health Sciences Centre
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Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa Heart Institute
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Quebec
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Montreal, Quebec, Canada, H1T 1C8
- Montreal Heart Institute
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-
-
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Hospital Center
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Florida
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Gainesville, Florida, United States, 32610-0277
- University of Florida
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Michigan
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Grand Rapids, Michigan, United States, 49525
- Spectrum Health
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Established diagnosis of unstable angina or NSTEMI with one or more episodes of angina in the 24 hours before hospital admission
- Scheduled for PCI
Exclusion Criteria:
- CABG within 6 months
- Acute ST elevation, eligible for thrombolysis on initial examination
- Coronary lesions with total thrombotic occlusions
- Current immunosuppressant therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety (Adverse events collected until 6 months post-dose)
|
Secondary Outcome Measures
Outcome Measure |
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Inflammatory marker analysis
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MACE
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Restenosis at 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Alexandra Lucas, MD, Chief Clinical Officer- Viron Therapeutics
- Study Chair: Jean-Claude Tardif, MD, Director- Montreal Heart Institute Research Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
October 19, 2005
First Submitted That Met QC Criteria
October 19, 2005
First Posted (Estimate)
October 21, 2005
Study Record Updates
Last Update Posted (Estimate)
February 6, 2009
Last Update Submitted That Met QC Criteria
February 5, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pain
- Neurologic Manifestations
- Coronary Disease
- Chest Pain
- Angina Pectoris
- Coronary Stenosis
- Coronary Artery Disease
- Myocardial Ischemia
- Atherosclerosis
- Acute Coronary Syndrome
- Angina, Unstable
- Coronary Restenosis
Other Study ID Numbers
- Serp-1-01-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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